Antiplatelet Therapy for Silent Brain Infarction

Brain Infarction Clinical Trial

— ANTISBI  

Official title:

Antiplatelet Therapy in Secondary Prevention for Patient With Silent Brain Infarction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03318744
• Other study ID #: FirstPHShenyang
• Status: Not yet recruiting
• Phase: N/A
• First received: October 19, 2017
• Last updated: October 24, 2017
• Start date: January 2018
• Est. completion date: December 2021

Study information

• Verified date: October 2017
• Source: First People's Hospital of Shenyang
• Contact: Yi Sui, MD PhD
• Phone: +86 24 31956417
• Email: jakeyisui[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Silent brain infarction (SBI) or incidental infarct is common. Recent studies revealed individuals with SBI have an increased risk of future stroke. Even though the 2014 AHA/ASA recommendation for ischemic stroke and transient ischemic attack considered SBI as an entry point for secondary prevention, convincing evidence with regard to the preventive efficacy of antiplatelet therapy against incident stroke in SBI is scant. Investigators examine if antiplatelet therapy can effectively decrease the incidence of future stroke in SBI individuals.

Description:

SBI is defined as a focal hyperintense lesion on T2-weighted images and/or fluid-attenuated inversion recovery with no corresponding symptoms in the clinical history of the patient that could be attributed to the lesion. SBI were distinguished from nonspecific subcortical and periventricular white matter lesions by the presence of a corresponding hypointense lesion on T1-weighted images.

The prevalence of SBI varies from 5% to 62% in healthy population. To date, few studies investigate the association between SBI and ethnicity. The effectiveness of antithrombotics including aspirin against future symptomatic stroke in SBI patients remains to be established. Due to the high prevalence of ICAS among Chinese, and its nature of artery-to-artery microembolisms, investigators hypothesize that the prevalence of SBI among Chinese might be significantly higher than other races such as Caucasians and African-Americans.

Recent study has revealed that SBI is associated with an 2-fold increase of future ischemic stroke. Yet, interventions such as antiplatelet therapies for reducing the stroke risk in SBI patients have not been investigated to our best knowledge. In this study, investigators examine whether regular oral aspirin can reduce the incidence of cerebrovascular events and mortality in SBI patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3400
• Est. completion date: December 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• cerebral infarction(s) identified by CT/MRI (= 3mm in diameter)

• absence of signs or symptoms of neurological dysfunction ascribed to the lesion(s)

• absence of PMH of neurological dysfunctions due to CNS lesion(s)

Exclusion Criteria:

• Age under 45 years or above 80 years

• PMH of ICH within 180 days

• PMH of lobar hemorrhage of anytime

• Neuroimaging evidence suggesting cerebral microbleeds

• High risk of bleeding (e.g. recurrent gastrointestinal or genitourinary bleeding, active peptic ulcer disease)

• Anticipated requirement for long-term use (more than 28 days) of anticoagulants (e.g. recurrent deep vein thrombosis)

• Prior long-term use of anticoagulants (more than 28 days) or antiplatelet agents (more than 28 days)

• Prior retinal stroke/TIA (diagnosed either clinically or by imaging)

• Intolerance or contraindications to aspirin (including thrombocytopenia, prolonged INR)

• Prior ipsilateral carotid endarterectomy/stent

• Stenosis of culprit artery = 70% (detected by ultrasound, MRA, CTA or DSA)

• Atrial fibrillation, or acute myocardial infarction, or acute congestive heart failure

• Impaired renal function: glomerular filtration rate<60

• Mini Mental Status Examination score<24 (adjusted for age and education)

• Medical contraindication to MRI

• Pregnancy or women of child-bearing potential who are not following an effective method of contraception

• Unable or unwilling to provide informed consent

• Unlikely to be compliant with therapy/unwilling to return for frequent clinic visits

• Patients concurrently participating in another study with an investigational drug or device

• Independence ascribed to limb deformity or prior disability

• Acute myocardial infarction

• Acute congestive heart failure

• Other anticipated reasons for future application of antiplatelet agents other than aspirin (eg. recent stenting, interventional surgeries, Lower-Extremity Atherosclerotic Arterial Disease etc)

Related Conditions & MeSH terms

• Brain Infarction
• Infarction

Intervention

Drug:
• Aspirin
Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke.
• Placebo Oral Tablet
Placebo resembling aspirin tablet will be be given to participants in control arm.

Locations

Country	Name	City	State
China	Shenyang Brain Hsopital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Shenyang

Country where clinical trial is conducted

China, 

References & Publications (7)

Caplan LR, Hennerici M. Impaired clearance of emboli (washout) is an important link between hypoperfusion, embolism, and ischemic stroke. Arch Neurol. 1998 Nov;55(11):1475-82. Review. — View Citation

Chou CC, Lien LM, Chen WH, Wu MS, Lin SM, Chiu HC, Chiou HY, Bai CH. Adults with late stage 3 chronic kidney disease are at high risk for prevalent silent brain infarction: a population-based study. Stroke. 2011 Aug;42(8):2120-5. doi: 10.1161/STROKEAHA.110.597930. Epub 2011 Jun 23. — View Citation

Gupta A, Giambrone AE, Gialdini G, Finn C, Delgado D, Gutierrez J, Wright C, Beiser AS, Seshadri S, Pandya A, Kamel H. Silent Brain Infarction and Risk of Future Stroke: A Systematic Review and Meta-Analysis. Stroke. 2016 Mar;47(3):719-25. doi: 10.1161/STROKEAHA.115.011889. Review. — View Citation

Nakagawa T, Sekizawa K, Nakajoh K, Tanji H, Arai H, Sasaki H. Silent cerebral infarction: a potential risk for pneumonia in the elderly. J Intern Med. 2000 Feb;247(2):255-9. — View Citation

Smith EE, Saposnik G, Biessels GJ, Doubal FN, Fornage M, Gorelick PB, Greenberg SM, Higashida RT, Kasner SE, Seshadri S; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Functional Genomics and Translational Biology; and Council on Hypertension. Prevention of Stroke in Patients With Silent Cerebrovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e44-e71. doi: 10.1161/STR.0000000000000116. Epub 2016 Dec 15. Review. — View Citation

Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30. — View Citation

Weber R, Weimar C, Wanke I, Möller-Hartmann C, Gizewski ER, Blatchford J, Hermansson K, Demchuk AM, Forsting M, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Risk of recurrent stroke in patients with silent brain infarction in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) imaging substudy. Stroke. 2012 Feb;43(2):350-5. doi: 10.1161/STROKEAHA.111.631739. Epub 2012 Jan 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite outcome with any incident stroke, myocardial infarction and all-cause death		24 months
Secondary	ischemic stroke, intracranial cerebral hemorrhage, any bleeding, independence (mRS=2)		24 months